iSONEP: Lpath intiates patient enrollment in PEDigree clinical trial
Lpath intiates patient enrollment in PEDigree clinical trial
PBR Staff Writer Published 08 April 2011
Lpath has commenced patient recruitment in PEDigree clinical trial of iSONEP, the company's ocular drug candidate, in patients who are suffering from retinal pigment epithelium detachment (PED).
The Phase 1b/2a trial will recruit 32 subjects, and will be given up to three monthly intravitreal injections of iSONEP, and two dose levels will be evaluated.
San Diego-based Lpath said that the primary safety endpoint of the study is the tolerability of consecutive monthly injections, and the primary efficacy endpoint is the percentage of subjects that experience flattening of their PED.
In the Phase I trial, subjects with wet age-related macular degeneration AMD received only one injection of iSONEP where the trial met its primary endpoint of being well tolerated in all 15 patients and also met a key secondary endpoint of positive biological effect.
Lpath intends to start another iSONEP trial in June of this year, a Phase 2 human-proof-of-concept trial to study the efficacy and safety of iSONEP in wet AMD patients that do not have PED.
Lpath Ocular Division head Glenn Stoller said iSONEP is a first-in-class drug that has distinguished itself with promising animal data and, more recently, human data.
"A growing body of literature suggests that iSONEP's distinctive anti-inflammatory, anti-angiogenic and anti-fibrotic mechanisms could prevent both the early and the late stages of retinal damage, including the damage that often results when a PED fails to flatten over time," Stoller said.
In 2010 Lpath had granted Pfizer a worldwide license to develop and commercialize iSONEP.